University of Minnesota Reprimanded for Questionable Reporting in Psych Studies
University of Minnesota reports on their industry-funded drug trials were recently audited – after evaluation there were multiple critical information lapses found in the reporting.
Details about the Psych Studies Reports at the University of Minnesota
According to the StarTribune, Legislative Auditor James Nobles discovered that the psychiatric drug trial reports done by the University of Minnesota lacked important details such as adverse events, injuries, and dates.
The audit of the reports found multiple cases where over the past decade of research key dates of when certain events occurred were left out in the reporting. This raises considerable concern due to the fact that researchers have deadlines to report adverse events to an internal safety and ethics panel, known as the University of Minnesota’s Institutional Review Board (IRB).
Joe Alter, evaluation coordinator for the state legislative auditor, said that in regards to the safety and ethics panel “you kind of have to know the date it occurred to know whether the researchers complied with the standards”.
Audit Results Leadership and Reporting Changes
In aftermath of the audit the University of Minnesota’s vice president of research, Brian Herman, stated on Thursday that the school has made changes to where researchers will be compelled to provide more information about the adverse events to IRB. Herman also said, that in addition to the IRB the researchers have been reporting to government agencies or private companies funding their work.
It was earlier this year that auditor James Nobles released a very serious audit of the University of Minnesota’s recruitment and treatment of Dan Markingson. Markingson was a patient who died by committing suicide while participating in a University of Minnesota drug trial for schizophrenia drugs.
Following this report the chairman of the university’s Psychiatric Department stepped down and the university suspended patient recruiting into psychiatric drug trials.
There is now a $5.5 million allotment for an electronic reporting system of adverse events to the IRB, which should according to Brian Herman make it easier for researchers to provide in depth reports.
Adverse Events Missing in the Reports
Adverse events include hospitalizations, injuries, or significant impairments to patients who were participating in the drug trials.
Left out in the reports were incidents such as when in 2010 a sex offender living in a Minneapolis treatment facility mixed antipsychotic medication as part of a study into the breakfast oatmeal for all other residents.
Other hospitalizations that occurred appeared to be unrelated to the drug trials the patients were involved in. However, Joe Alter said that the researchers should have provided information about the events anyways and have left it up to the review board as of to whether or not they were relevant.